Mesalamine (10 brand names, 5 dosage forms, 2 routes)
Available dosage forms: SUPPOSITORY, ENEMA, TABLET, DELAYED RELEASE, CAPSULE, EXTENDED RELEASE, CAPSULE, DELAYED RELEASE.
Routes of administration: RECTAL, ORAL.
Brand Names
- APRISO
- ASACOL
- ASACOL HD
- CANASA
- DELZICOL
- LIALDA
- MESALAMINE
- PENTASA
- ROWASA
- SFROWASA
Indications and Usage
Mesalamine extended-release capsules are indicated for the induction of remission and for the treatment of mildly to moderately active ulcerative colitis in adult patients.
Dosage and Administration
Evaluate renal function prior to initiation of mesalamine extended-release capsules and periodically while on therapy [see Warnings and Precautions (5.1)] . Recommended Dosage The recommended dosage for the induction of remission and the symptomatic treatment of mildly to moderately active ulcerative colitis in adults is 1 g (4 mesalamine extended-release 250 mg capsules or 2 mesalamine extended-release 500 mg capsules) administered orally four times daily. Administration Instructions Swallow mesalamine extended-release capsules whole; do not crush or chew. Alternatively, the capsule(s) may be opened and the entire contents sprinkled onto applesauce or yogurt. Consume the entire mixture immediately. Drink an adequate amount of fluids during treatment [see Warnings and Precautions (5.7)] .
Contraindications
Mesalamine is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or any ingredients of mesalamine extended-release capsules [see Warnings and Precautions (5.3)] .
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: Renal impairment [see Warnings and Precautions (5.1)] Mesalamine-induced acute intolerance syndrome [see Warnings and Precautions (5.2)] Hypersensitivity reactions [see Warnings and Precautions (5.3)] Hepatic failure [see Warnings and Precautions (5.4)] Severe cutaneous adverse reactions [see Warnings and Precautions (5.5)] Photosensitivity [see Warnings and Precautions (5.6)] Nephrolithiasis [see Warnings and Precautions (5.7)]
Mechanism of Action
The mechanism of action of mesalamine is not fully understood, but it appears to be a topical anti-inflammatory effect on colonic epithelial cells. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways (i.e., prostanoids) and through the lipoxygenase pathways (i.e., leukotrienes and hydroxyeicosatetraenoic acids), is increased in patients with ulcerative colitis, and it is possible that mesalamine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon.
Overdosage
Mesalamine is an aminosalicylate, and symptoms of salicylate toxicity may be possible, such as: nausea, vomiting, abdominal pain, tachypnea, hyperpnea, tinnitus, and neurologic symptoms (headache, dizziness, confusion, seizures). Severe intoxication with salicylates may lead to electrolyte and blood pH imbalance and potentially to other organ (e.g., renal and liver) damage. There is no specific antidote for mesalamine overdose; however, conventional therapy for salicylate toxicity may be beneficial in the event of acute overdosage and may include gastrointestinal tract decontamination to prevent further absorption. Correct fluid and electrolyte imbalance by the administration of appropriate intravenous therapy and maintain adequate renal function.